FDA.reportPublic FDA data

510(k) K021140

Device
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
Applicant
Fossa Industries, Inc.
510(k) number
K021140
Product code
FAD
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-28
Date received
2002-04-09
Regulation
876.4620
Classification name
Stent, Ureteral
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
GLORIA KOLB
Address
580 Harrison Ave., 4th Floor Boston MA US 02118 02118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAD#

510(k), Device, Applicant table
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K201436Vortek Single Loop Ureteral StentColoplast Corp.2021-02-25
K191446Ureteral Stent Systems, Biliary Drainage CathetersBoston Scientific Corporation2020-01-02
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